Retrofitting CIP into API Plants
by Nigel A. FletcherThis article describes the physical modifications and additions retrofitted into existing plants to incorporate CIP technology and some of the techniques that can be used to ‘stretch’ the existing CIP systems for best effect.Download Article...
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Solving the Terminology Conundrum
by Robert Adamson, Nuala Calnan, Robert E. Chew, Steven J. WisniewskiThis article discusses the terms “commissioning,” “qualification,” and “verification.” Do the terms refer to the same or different ideas? How should the pharmaceutical and biotechnology industries use these terms in a consistent and meaningful way? This article provides a compilation of how these terms are used in regulations and by various industries, and provides a proposal for clear definitions to be used as ISPE updates and creates Baseline® Guides.Download Article...
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